If the FDA is allowed to publish new guidelines for the marketing of off-label drug use, it would be a drug company’s dream come true. Presently, doctors may determine the proper method of prescribing a drug for off label use. However, the pharmaceutical company may not market or promote in any fashion that off-label use. However, the FDA wants to give the drug companies some room to do just that. Luckily, Congressman Henry Waxman (D-CA) doesn’t think that’s such a good idea. Drugs can be dangerous enough without allowing the greedy, hyped-up marketing machine of big-pharma in on the act. Waxman warned the FDA that such approval would “allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns.” This is a very bad idea. If approved, consumer safety will be at an even greater risk.

Heparin deaths and allergic reactions appear to extend beyond the nine lots disclosed by Baxter a week ago according to a Wall Street Journal Report on Thursday February 14,2008. Heparin is used for a wide variety of medical procedures to prevent clotting such as kidney dialysis and open heart surgery. Baxter did not suspend sales of heparin because it markets about 50% of the heparin on the market and suspension of sales would cause a shortage. This decision was made in consultation with the U.S. Food and Drug Administration. Baxter confirmed to the Wall Street Journal that it gets the active pharmaceutical ingredient for heparin from a Chinese factory that had not been inspected. Our firm is investigating these cases and I expect that we will discover that again the FDA is understaffed and underfunded to protect the public from the danger of poor manufacturing practices in China.

Baxter Healthcare has announced the recall of its blood thinner Heparin. The recall involves 9 lots of the blood thinning drug. The lots involved in the recall are 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111.
The drugs were manufactured in a Chinese factory that eluded an FDA inspection. The factory was supposed to have had an inspection but, due to human error, the inspection never took place.

Once again, it seems to be the Chinese involved in a consumer product recall. This time, it’s Baxter Healthcare’s Heparin, a blood thinner widely used by patients in this country. The FDA has admitted that the plant should have been inspected, in fact, it was scheduled to be inspected, but it was not inspected. The FDA attributes the non-inspection to human error. This past Monday, the company announced it was suspending production of Heparin because of 350 reactions (including 4 deaths) linked to the drug. 40% of the reactions were considered serious by the FDA. Symptoms include stomach pain, vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting.
Please be sure to visit our Defibrillator Information Website with up To the Minute Sprint Fidelis Lead Class Action Attorney and Medtronic Lawyer Lawsuit news and information regarding the Sprint Fidelis Defibrillator Lead Lawsuit.
Sprint Fidelis Lead Recall Lawyer Page On Our Main Website
http://www.fda.gov/cder/drug/infopage/heparin/heparinQA.htm

Once again, it seems to be the Chinese involved in a consumer product recall. This time, it’s Baxter Healthcare’s Heparin, a blood thinner widely used by patients in this country. The FDA has admitted that the plant should have been inspected, in fact, it was scheduled to be inspected, but it was not inspected. The FDA attributes the non-inspection to human error. This past Monday, the company announced it was suspending production of Heparin because of 350 reactions (including 4 deaths) linked to the drug. 40% of the reactions were considered serious by the FDA. Symptoms include stomach pain, vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting.
Please be sure to visit our Defibrillator Information Website with up To the Minute Sprint Fidelis Lead Class Action Attorney and Medtronic Lawyer Lawsuit news and information regarding the Sprint Fidelis Defibrillator Lead Lawsuit.
Sprint Fidelis Lead Recall Lawyer Page On Our Main Website

Yesterday, I filed a lawsuit against a visiting priest from India and the Diocese of Pensacola-Tallahassee. The priest, Fr. Vijay molested a 15 year old girl two years ago. He was adjudicated guilty and kicked out of the country. However, no one knows if Catholics in Inddia know about this molesting priest. He may be molesting other children.
Today, I’m in Jacksonville preparing to file a sex abuse lawsuit against the Diocese of St. Augustine for the abuse one of its priests, Fr. William Weinheimer, perpetrated against a young boy while he attended St. Mary’s Academy in Jacksonville. The boy’s family kept letters from the priest which intimated sexual abuse. The abuse occurred in the 1950’s but the now adult man still can’t come to grips with the effects of the abuse.

While the preliminary report from the FDA on Botox was careful in discussing the potential dangers of Botox, one thing is clear, the benefits from Botox injections are unclear at best. However, the worst side effects appear to be in children with cerebral palsy. The adverse symptoms associated with Botox are similar to those of botulism, including difficulty swallowing, breathing problems and weakness.

I wish I could say that the priest abuse crisis is over. I wish I could say that institutions like the Catholic Church had made enough changes to stop the awful scourge of the sexual abuse of minors. This week, I’ll be filing three new lawsuits in Florida against Catholic priests and the Dioceses that allowed them to prey on children. Until we have transparency in the Catholic Church the potential for abuse continues.
Priest Abuse Lawyer & Church Abuse Attorney Information On Abuse Advocate Center ( abuseadvocate.com )

The crash accident report for the January 9, 2008 chain auto truck pile up was released by the Florida Highway Patrol this week and does not mention the smoke from the fire that Florida state employees let get out of control. The chain reaction collision on the Florida interstate between Lakeland and Tampa caused 5 deaths and 38 injuries. The cause of the chain pile up was a combination of smoke and fog that reduced visibility to zero. However, the newly released 120 page crash report does not even mention to role of the careless and negligent state employees that let a fire get out of control. Perhaps we need an independant investigation. Here we have the state employees of the highway patrol investigating other state employees of the Department of Forestry. However,some comments from Florida Highway Patrol Trooper Coggins are encouraging in that there may be some follow up investigation on the role that the smoke played in this horrific crash.

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FDA Notifies Public of Adverse Reactions Linked to Botox Use
Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place
The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
In an early communication based on the FDA’s ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.
The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.
The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.
The FDA is not advising health care professionals to discontinue prescribing these products.
The agency is currently reviewing safety data from clinical studies submitted by the drugs’ manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.
The notification is in keeping with the FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
Botox Class Action Attorney / Lawsuit Lawyer Information Center